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Text Messaging and Cognitive Behavioral Therapy for Depression (HealthySMS)

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ClinicalTrials.gov Identifier: NCT01083628
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This study aims to asses whether adding automated text messaging to group cognitive behavioral therapy for depression increases engagement which may lead to improved outcomes.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Group CBT for Depression with MoodText Behavioral: Group CBT for Depression Not Applicable

Detailed Description:

Background: Cognitive Behavioral Therapy (CBT) for depression is efficacious, but effectiveness is limited when implemented in low-income settings due to engagement difficulties including nonadherence with skill-building homework and early discontinuation of treatment. Automated messaging can be used in clinical settings to increase dosage of depression treatment and encourage sustained engagement with psychotherapy.

Objectives: The aim of this study was to test whether a text messaging adjunct (mood monitoring text messages, treatment-related text messages, and a clinician dashboard to display patient data) increases engagement and improves clinical outcomes in a group CBT treatment for depression. Specifically, the investigators aim to assess whether the text messaging adjunct led to an increase in group therapy sessions attended, an increase in duration of therapy attended, and reductions in Patient Health Questionnaire-9 item (PHQ-9) symptoms compared with the control condition of standard group CBT in a sample of low-income Spanish speaking Latino patients.

Methods: Patients in an outpatient behavioral health clinic were assigned to standard group CBT for depression (control condition; n=40) or the same treatment with the addition of a text messaging adjunct (n=45). The adjunct consisted of a daily mood monitoring message, a daily message reiterating the theme of that week's content, and medication and appointment reminders. Mood data and qualitative responses were sent to a Web-based platform (HealthySMS) for review by the therapist and displayed in session as a tool for teaching CBT skills.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Automated Text Messaging to Increase Engagement in Cognitive Behavioral Therapy (CBT) for Depression
Study Start Date : January 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group CBT for Depression with MoodText'
Group cognitive behavioral therapy utilizing the BRIGHT manual for depression along with automated text messaging for mood monitoring and reminder of session content
Behavioral: Group CBT for Depression with MoodText
Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Other Name: Group CBT for Depression with HealthySMS

Active Comparator: Group CBT for Depression
Standard group cognitive behavioral therapy utilizing the BRIGHT manual for depression
Behavioral: Group CBT for Depression
Standard group CBT for depression using BRIGHT manual




Primary Outcome Measures :
  1. PHQ-9 Depression Symptoms [ Time Frame: 16 weeks ]
    The PHQ-9 (Patient Health Questionnaire - 9) is commonly used to screen for depression and to monitor progression of depressive symptoms over time. The scores represent the following depression severity: 0-4: minimal depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe, 20-27: severe. A score of 10 is often recommended as the cut-off score for diagnosing an episode of depression that may require treatment.


Secondary Outcome Measures :
  1. Attendance [ Time Frame: 16 weeks ]
    Number of sessions attended

  2. Duration of Therapy Attended [ Time Frame: 16 weeks ]
    Number of weeks until patients dropped out of therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in CBT group at San Francisco General Hospital

Exclusion Criteria:

  • Active suicidality
  • Active and severe psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083628


Locations
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United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Adrian Aguilera, Ph.D. University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01083628    
Other Study ID Numbers: 68556-35551-01
First Posted: March 10, 2010    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
mhealth
depression
latinos
text messaging
CBT
SMS
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders